Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Viscocel and Viscocel Plus CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspection findings of deficiencies in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alaris PC unit CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Integra Cranial Access Kit Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13 An anomaly has been traced to a software deficiency within the Plan Parameters workspace. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PedFuse Reset Screw Inserters Screw inserters may not mate properly with hex interface of the screws. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Florida, Illinois, New York, Ohio, Texas and Virginia
- Medical device recall PedFuse Reset Screw Inserters Screw inserters may not mate properly with hex interface of the screws. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Florida, Illinois, New York, Ohio, Texas and Virginia
- Medical device recall PedFuse Reset Screw Inserters Screw inserters may not mate properly with hex interface of the screws. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Florida, Illinois, New York, Ohio, Texas and Virginia
- Medical device recall McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy… Class IIFDA’s classJan 1, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereMissouri, New York, Tennessee and West Virginia
- Medical device recall VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent… Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HT Connect Peripheral Guide Wire Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE… Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B.… One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Class IIIFDA’s classJan 1, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJan 1, 2014ClassClass IIIStatusTerminatedWhereFlorida
- Medical device recall Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the… Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when… Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System Engineering change in 2006 resulted in a minor non-conformity of their devices. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System Engineering change in 2006 resulted in a minor non-conformity of their devices. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System Engineering change in 2006 resulted in a minor non-conformity of their devices. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System Engineering change in 2006 resulted in a minor non-conformity of their devices. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System Engineering change in 2006 resulted in a minor non-conformity of their devices. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System Engineering change in 2006 resulted in a minor non-conformity of their devices. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System Engineering change in 2006 resulted in a minor non-conformity of their devices. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the… MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions… When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005,… Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG… Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Washington named
- Medical device recall Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered Mismarked and unmarked screws Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, District of Columbia, Indiana, Kansas, Massachusetts, Michigan, New York, Ohio and Texas named
- Medical device recall Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling Mismarked and unmarked screws Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, District of Columbia, Indiana, Kansas, Massachusetts, Michigan, New York, Ohio and Texas named
- Medical device recall Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping Mismarked and unmarked screws Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, District of Columbia, Indiana, Kansas, Massachusetts, Michigan, New York, Ohio and Texas named
- Medical device recall Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling Mismarked and unmarked screws Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, District of Columbia, Indiana, Kansas, Massachusetts, Michigan, New York, Ohio and Texas named
- Medical device recall ProPlan CMF Guide(s) Patient Specific Guide contained the incorrect case report. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ProPlan CMF Guide(s) Patient Specific Guide contained the incorrect case report. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system… Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Ohio, Rhode Island and Tennessee named
- Medical device recall steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product… Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery. Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery. Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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